SAN FRANCISCO and SUZHOU, China, Dec. 10, 2020 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, today announces that the first patient has been successfully enrolled and dosed in the randomized, double-blind, phase 2 multi-center clinical trial (NCT04590599) evaluating its IBI310 (anti CTLA-4 monoclonal antibody) in combination with TYVYT® (sintilimab injection) for the treatment of patients with second-line or above advanced cervical cancer.
The trial is a randomized, double-blind, controlled, parallel cohort phase 2 clinical trial evaluating the efficacy and safety of IBI310 versus placebo, in combination with TYVYT® (sintilimab injection), for advanced cervical cancer patients who have failed first and later line or intolerant of platinum-based chemotherapy. This clinical trial plans to enroll 174 patients with advanced cervical cancer.
Primary Investigator of the study, Professor Ding Ma of Tongji Hospital affiliated to Huazhong University of Science and Technology, stated:" Cervical cancer is the 4th most common malignant tumor among women in the world. in China, it ranks the 6th highest incidence rate (154/100,000) and 8th highest mortality rate (69/100,000) across tumor types. Treatment option of advanced cervical cancer is limited. The five-year survival rate of Stage IVb cervical cancer is still at a low level of less than 17%. Currently there is no standard treatment for patients with advanced cervical cancer who have failed platinum-based chemotherapy, representing a huge unmet clinical need. In recent years, immune checkpoint inhibitors have brought new hope to such patient population. We hope to explore the therapeutic value of the regimen of IBI310 in combination with TYVYT® (sintilimab injection) as second-line or above treatment for patients with advanced cervical cancer."
Dr. Hui Zhou, Vice President and Head of Medical Sciences and Oncology Strategy of Innovent, stated: "CTLA-4 is an important immunosuppressive receptor. Currently, only one antibody drug targeting CTLA-4 has been approved and marketed globally, though lots of clinical trials on CTLA-4 targeted drugs have been conducted. So far there is no CTLA-4 targeted drug approved in China. With the most advanced progress in clinical development in China, IBI310 in combination with TYVYT® (sintilimab injection) has shown promising preliminary anti-tumor potential value. We will evaluate the efficacy of IBI310 combined with TYVYT® (sintilimab injection) in the phase II trial and we hope to provide more effective treatment to benefit patients and their families.
Innovent Biologics, Inc. (Innovent), a world-class biopharmaceutical Chinese company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, today announced that the first patient has been successfully dosed in Phase 1 clinical trial (CIBI322A101) of the potentially first-in-class recombinant anti-CD47/PD-L1 bispecific antibody (IBI322) in China.
CIBI322A101 is a Phase 1a/1b clinical study conducted in China to evaluate IBI322 in the treatment of patients with advanced malignancies. The primary objective of the study is to evaluate the safety, tolerability, and initial anti-tumor efficacy of IBI322 in patients with advanced malignancies who have failed standard therapy.
IBI322 is a recombinant anti-CD47/PD-L1 bispecific antibody that blocks both the PD-1/PD-L1 and CD47/ SIRP-α pathways. Pre-clinical studies showed that IBI322 can effectively block CD47–SIRP-α interactions and induce macrophages to phagocytize CD47 expressed tumor cells, which is equivalent to anti-CD47 monoclonal antibody.
IBI322, on the other way, effectively blocks the binding of PD-1 to PD-L1 and activates CD4+T lymphocyte, which is comparable to anti-PD-L1 monoclonal antibody. Because of PD-L1 expression on tumor cells, IBI322 can selectively bind to tumor cells more potent than anti-CD47 monoclonal antibody, thus reducing the possibility of bind to CD47 on red blood cells, which could ultimately reduce the toxicity associated with anti-CD47 antibodies. Therefore, IBI322 has better antitumor activity and a higher safety profile.
